Plain English Summary

Background and study aims Radical prostatectomy is the surgical removal of the prostate gland. It is the most common treatment for localised prostate cancer (cancer that is just in the prostate gland). The type of surgical technique to use is debated. Laparoscopy allows a surgeon to access the inside of the abdomen (tummy) and pelvis without having to make large incisions in the skin. Robots are being increasingly used to assist with these procedures - this is known as robot-assisted laparoscopy. However, no studies have reported that it is clearly more effective than traditional open surgery. The aim of this study is to compare robot-assisted laparoscopy with open radical prostatectomy.

Who can participate? Men aged up to 75 with localised prostate cancer.

What does the study involve? The included patients were operated by one of the two surgical techniques (robot-assisted laparoscopy or open radical prostatectomy), not by personal or surgeon's preference, but according to the hospital where there were operated on.

What are the possible benefits and risks of participating? The benefits of participating were that follow-up was more consistent and efforts were made to ensure that all patients who consented to participation were recalled for follow-up as planned. Another possible benefit was that all participants were asked to fill out detailed questionnaires at four time points. Before sending out questionnaires all men were contacted both by letter and by phone. Many of them found the phone call beneficial. The risks were of the general kind with any new treatment, i.e. outcomes are not known for the new technique, but as the robot-assisted laparoscopic operation had already been implemented in some of the participating hospitals, the participating men would have received that kind of treatment even without participating in the study.

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sahlgrenska University Hospital ALFGBG-11314

Study information

Scientific title

LAPPRO: LAParoscopic Prostatectomy Robot Open - a randomised, open trial of radical prostatectomy with or without lymph node dissection as part of a prospective, non-randomised, open trial comparing robot-assisted laparoscopic and open radical prostatectomy

Acronym

LAPPRO

Study hypothesis

Robot-assisted laparoscopic radical prostatectomy, compared with open radical prostatectomy, results in fewer patients with chronic complications such as incontinence and impotence without changes of the oncological result.

Primary study design

Secondary study design

Trial setting

Trial type

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prostate cancer

Intervention

Initial information at time of registration:Group A: Traditional radical prostatectomy by open surgical approach Group B: Radical prostatectomy by robot-assisted laparoscopic approach

In both groups, the patients who fulfill the inclusion criteria for the randomised trial will be allocated to prostatectomy with or without regional lymph node dissection. This randomisation will be stratified per hospital and include therefore both open and robot assisted operations.

Current information as of 02/09/2009:Group A: Traditional radical prostatectomy by open surgical approach Group B: Radical prostatectomy by robot-assisted laparoscopic approach

Added 03/11/2009: An interim analysis by a committee of three independent scientists, not involved in any other sense in the LAPPRO trial, will be performed when about 400 patients have been included in the open prostatectomy group. The data manager will send data regarding the primary outcome, variable incontinence, for the two groups with and without age adjustment. Neither the principal investigator (PI), nor the deputy PI or any other individual within the actual trial steering committee or administration will have access to these interim results. The interim analysis group will be asked to give advice regarding the numbers of accrual as stated in the protocol (700 + 700) in view of the interim result and whether inclusion should continue beyond 700 individuals in each group or if accrual can safely be finished before this level and in that case give a suggestion about numbers needed. The date set for the interim analysis (based on accrual) is 1 December 2009.

Added 11/05/2010: The interim analysis group adviced to continue the inclusion until 700 (open) + 1400 (robot) operations performed by surgeons with an experience >100 procedures. This should make it possible to report a significant difference of 5% in urinary leakage bewteen groups. The Ethical Committee has given approval for this enlarged trial population to be included. Inclusion rate is about 110 patients per month. The prognosis shows that the accrual should be reached by October 2011.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Erectile dysfunction and urinary leakage within 24 months of radical prostatectomy. The evaluation of these symptoms will be through detailed self evaluation questionnaires, specifically constructed and validated for this population. The questionnaires will be answered before and 3, 12 and 24 months after the operation. Similar techniques have been used before in a large Swedish randomised trial comparing open radical prostatectomy to 'watchful waiting' in early prostate cancer.

Added 04/01/2011:The definition of urinary incontinence used for the interim analysis was incontinence = change of pad/equivalent once daily or more. This definition will be used for the analysis of the primary end-point incontinence 12 months postoperatively.

Secondary outcome measures

1. Radicality as judged by the pathology report of the operation specimen. The report will be stratified for all including hospitals including pT stage, growth in resection line, N-stage and Gleason score 2. Oncological result judged by PSA relapse, defined as a PSA >0.2 to be determined at 3, 12 and 24 months after the operation 3. Operating time 4. Blood transfusions 5. Re-operations 6. Length of hospital stay 7. Re-admittance 8. Length of sick leave 9. Length of catheter treatment 10. Continued urinary leakage and erectile dysfunction 11. Inguinal hernia 12. Short term complications of any kind 13. Mortality and complications within 3 months, due to regional lymph node dissections 14. Self evaluated health related quality of life using a specifically constructed instrument, based on questionnaire used for the primary outcome measure. The instrument has been re-validated after revision. 15. Health economy analyses, based on variables described above and also including Quality-Adjusted Life Year (QALY) using the EuroQol (EQ-5D) instrument, at 3, 12 and 24 months16. Long-term survival through Swedish Cancer Registry

Added 03/11/2009:17. Learning curve and factors that influence learning of the surgical technique18. An analysis will be performed of 'intrusive thoughts' in relation to health-related quality of life before and 3 months postoperatively for the patient population accrued by October 2009. The analyses will not include any information about the intervention group for the individual patients and thus no connection to treatment group will be made. The analyses will be made before full accrual has been reached.

Added 11/05/2010:Some data from the database for the entire population (defined as those included over the initial 12 months of the trial inclusion period) will be used to analyse some confounding factors. Data will not be retrieved by interventional group, but only for the entire population. These analyses will be made during 2010 and the first part of 2011. This will be in order to ensure a timely reporting of results once the accrual has reached the target size.

Overall trial start date

01/02/2008

Overall trial end date

07/11/2011

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current information as of 02/09/2009: 1. Men with localised prostate cancer, stage T1-T3 2. No signs of distant metastases, i.e. stage M0 3. Prostate-Specific Antigen (PSA) <=20 4. All Gleason gradings 5. The patient should in all other aspects be judged suitable for radical prostatectomy 6. The patient must accept the potential complications with the operation 7. Age <=75 years 8. No other cancer in case history

Added 03/11/2009:The accrual of patients includes every patient at each participating hospital, who gives informed consent, regardless of the experience of the surgeon. Thus the trial will also include patients operated by a surgeon in training (an experience of less than 100 cases). The total number of patients included will therefore surpass the numbers needed for the primary outcome variable.

Initial information at time of registration:1. Men with localised prostate cancer, stage T1-T2 2. No signs of distant metastases, i.e. stage M0 3. Prostate-Specific Antigen (PSA) <=20 4. All Gleason gradings 5. The patient should in all other aspects be judged suitable for radical prostatectomy 6. The patient must accept the potential complications with the operation 7. Age <=75 years 8. No other cancer in case history

Additional files

Editorial Notes

22/08/2016: publication reference added.
27/05/2014: the following changes were made to the trial record:
1. The overall trial end date was changed from 01/08/2010 to 07/11/2011.
2. The target number of participants was changed from 2100 to 4000.
12/05/2010: the target number of participants was changed from 1400 to 2100.